Medical research ethics: more than abuse prevention?

By Henry S. Richardson
Oxford University Press Blog
Originally posted on October 20, 2013

Scholarly and regulatory attention to the ethics of medical research on human subjects has been one-sidedly focused on the prevention of moral disasters. Scandals such the US Public Health Service (PHS)’s Tuskegee syphilis experiments, which for decades observed the effects of untreated syphilis on the participants, most of whom were poor black sharecroppers, rightly spurred the broad establishment of a regulatory regime that emphasized the importance of preventing such severe harming and exploitation of the human subjects of research. Revelations in 2011 about a similarly horrific set of studies conducted by the PHS from 1946 to 1948 on sexually transmitted diseases has renewed this kind of concern, which has been strongly underlined in a recent report by the Presidential Commission for the Study of Ethical Issues.

The entire article is here.

Human Subjects Research Landscape Project – Analysis Dataset

The Presidential Commission for the Study of Bioethics

In order to respond to President Obama’s November 24, 2010 charge “to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government,” the Commission recognized that a critical first step would be to define and understand the landscape of “scientific studies supported by the Federal Government.” Finding no comprehensive publicly available source for this information, the Commission asked the 18 federal departments and agencies that have adopted the Common Rule—and therefore were likely to support scientific studies with human subjects—to provide basic project-level data for department/agency-supported human subjects research in Fiscal Year 2006 to Fiscal Year 2010.

These data, which include study title, number and location of sites, number of subjects, and funding information, were compiled into the Commission’s Research Project Database, and analyzed as part of its Human Subjects Research Landscape Project.

Posted here is the Commission’s analysis dataset, which incorporates minimal data cleaning as detailed in “Appendix II: Human Subjects Research Landscape Project Methods.”  Also posted is a data dictionary that defines the dataset’s fields. The data are available in two formats: Microsoft Access and .CSV.  The Access file contains the same information as the three .CSV files.

As detailed in the Methods, department/agency-reported information in the dataset was not independently audited or verified.  Moreover, the dataset is static; no additional data will be added to it.

For further information, and to read the Human Subjects Research Landscape Project Methods, please see “Appendix I: Human Subjects Research Landscape Project: Scope and Volume of Federally Supported Human Subjects Research” and “Appendix II: Human Subjects Research Landscape Project Methods.”

The entire study is here.